A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body. With the rise of smartphone usage in the medical space, in 2013, the FDA issued to regulate mobile medical applications and protect users from their unintended use, soon followed by European and other regulatory agencies. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. Incorporation of the guidelines during the development phase of such apps can be considered as developing a medical device; the regulations have to adapt and propositions for expedite approval may be required due to the nature of ‘versions’ of mobile application development.
The terms medical software and medical device software may be considered undefined terms that can designate any software, software item or system used within a medical context (e.g. medical devices that monitor or control patients are predominantly controlled by software), depending on its intended use/indication for use. The terms “medical device software” or “software medical device” or, less commonly, “software-as-a-medical-device”, may refer to a program or application or a product that is a standalone software system (not appended/integrated into a distinct product) AND meets the legal definition of a medical device (e.g. European medical devices directive MDD/93/42, updated in 2007 to explicitly include the term ‘software’).
The scope of the evolved regulatory definition of a medical device now explicitly includes the term “software” (and not simply software that is part of or within another product). As such, the following would be considered to fall under its scope: Software intended to analyze patient data generated by a medical device with a view to diagnosis and monitoring; Software that incorporates dosage algorithms for chronic conditions (e.g. diabetes); and Software intended for use by patients to diagnose or treat a physical or medical ailment (condition or disease).
It would be advantageous to use a smart phone as a medical device, making use of the audio jack on the smart phone or other computing device as a port for entering a medical instrument or sensor, thereby benefiting from the advantages to be gained by using the audio or earphone jack.